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Understanding lab tests

Posted by medconsumers on August 25, 2012

Always request copies of your medical test results. This may be the standard advice to consumers, but can you make sense of the report? There’s a place to go online for free help in understanding the results of a wide range of tests from the standard blood test to a bone marrow aspiration plus biopsy.

Lab Tests Online provides information that is far more in-depth than anything likely to be conveyed by the doctor who ordered the test. This website calls itself, “A public resource on clinical lab testing from the laboratory professionals who do the testing,” adding that its content is “peer reviewed, non-commercial and patient-centered.” This website can be accessed in 14 languages.

There are brief explanations of the diseases (e.g., Alzheimer’s disease) and conditions (e.g.,vitamin K deficiency) that account for most of the testing. You will learn what to expect from the test itself, get answers to frequently asked questions, and see how quality standards are established and maintained.  In some instances, the reliability of the test will get a brief critique, most notably for the relatively new test for prostate cancer, called the complexed PSA (cPSA).

Genetic testing and screening tests for healthy people—newborns to old age—are also part of the roster, along with the often contradictory recommendations from organizations like the National Osteoporosis Foundation and the U.S. Preventive Services Task Force.  If you have a specific question about a test or your own test results, you can submit a question that will be answered by a laboratory scientist.

This website is not without flaws. For example,  the urine test (urinalysis) is described as “often ordered for adults without symptoms as part of a routine health exam,” but the website fails to mention that this test got a thumbs down for men and nonpregnant women from the U.S. Preventive Services Task Force. Reason: “The harms of giving antibiotics to people with evidence of symptomless bacteria in the urine outweigh any benefit.”

There’s a similar lack of warning about the standard blood test, aka, blood chemistry panels, for people without symptoms, which is yet-another component of the routine health exam. Surprisingly, this test made the 2011 primary care physicians’ list of the most useless tests routinely administered by their peers. There are two exceptions: a blood test  for LDL cholesterol and for type 2 diabetes mellitus in symptomless adults with hypertension. This list was put together by working groups established by the National Physicians Alliance.  The list is one of ten developed by the Choosing Wisely campaign in order to improve the quality of medical care.

Still. This is a terrific website that is definitely worth a long visit whenever a test is ordered.

Maryann Napoli, Center for Medical Consumers©

Related posts:

45 tests or treatments to avoid  Nine different specialty organizations list the five most useless tests or treatments commonly administrered by their peers. Hardly any lab tests on the list, but this one’s a gem from the American Academy of Family Physicians:  “Don’t perform a pap test on women younger than 21 or who had a hysterectomy for non-cancer disease.”

When to just say no  This is about the 2011 primary care physicians’ list of useless tests. Unnecessary testing is more than an waste of time and money. False alarms and inconclusive results can escalate to riskier tests that also provide inconclusive results.

Posted in Screening, testing, Unnecessary tests | Tagged: , , , , , , , , , | 3 Comments »

Risks of treating diabetes 2

Posted by medconsumers on August 8, 2011

In keeping with the theme of this website—reporting the lack of evidence for common medical treatments—attention this week goes to drugs for type 2 diabetes. A new meta-analysis of the best studies on this topic shows strong hints that these drugs may cause more harm than good when intensive glucose (blood sugar) lowering is the goal. At best, there is a small reduction in non-fatal heart attacks among people treated intensely, at worst, an increase in cardiovascular deaths and deaths from all causes. All because blood sugar was intentionallly reduced to extremely low levels—ironically, in an effort to save type 2 diabetics from an early demise.

The meta-analysis included 13 randomized controlled trials with a combined total of over 33,000 type 2 diabetics given drugs to get their glucose levels down to what is defined as normal. The analysis of these trials was conducted by an international team of researchers and published recently in the British Medical Journal. To make sense of the findings, I turned to one of its co-authors, James M. Wright, MD, PhD, University of British Columbia, Vancouver, who acknowledged they were surprising. “One would expect that lowering glucose levels to normal [with drugs] would make people live longer; but we could find no reduction in mortality in these trials,” he explained. “If anything, mortality was increased by 4% in the people treated intensively [below normal].”

What exactly is “normal” and why was intensive lowering of glucose levels considered a treatment goal? To put the new findings in perspective, here’s the back-story for how type 2 diabetes became a common diagnosis:

-In 1998, the definition of diabetes was changed from a fasting blood sugar of 140 mg/dL to a blood sugar of 126 mg/dL, thus making millions of formerly healthy Americans into type 2 diabetics overnight and, not incidentally, candidates for long-term drug therapy. In time the A1C blood test, which provides a three- to four-month picture of past glucose levels, would be considered the better measure for assessing type 2 diabetes and the need for treatment.

-Most of the physician experts who served on the panel that expanded the definition of type 2 diabetes had financial ties to companies that make drugs for the condition. click here By 2009, an equally conflicted international panel of experts announced “the goal of therapy is to achieve a hemoglobin A1C of 6.5% or less.” click here  Unfortunately, there is no evidence to prove this current recommendation is safe or effective.

-Lowered thresholds for normal initially seemed to make sense. Observational studies showed type 2 diabetics die of heart disease at rates two to four times higher than people without it. Diabetics also have more heart attacks and strokes. What’s more, risks start to increase at glucose levels lower than what had previously been defined as normal.

-Will glucose-lowering drugs also lower the chances of dying a premature death or having a heart attack or stroke? The first clinical trial designed to answer that question, the ACCORD trial, had to be stopped 18 months ahead of schedule in 2008. More deaths had occurred in the participants treated intensively, compared to those treated to normal blood glucose levels. There was also higher rate of hypoglycemia in the intensively treated people, 10% of whom required medical care.

This disturbing recent history brings us full circle to the new meta-analysis of the 13 clinical trials (one of which is the ACCORD). The 18,315 study participants of these trials who had been treated intensively (to A1C of 6.6%) were compared with the 16,218 treated less intensively (to A1C of 7.5%). All participants were taking the usual drugs prescribed for type 2 diabetes; those treated intensively were more likely to use combinations of drugs and higher doses. The meta-analysis produced this alarming conclusion: “The overall results do not show a benefit of intensive glucose lowering treatment on all cause mortality or cardiovascular death. A 19% increase in all cause mortality and a 43% increase in cardiovascular mortality cannot be excluded.”

Dr. Wright, co-author of the meta-analysis and practicing physician, was asked how he treats his patients. “My target is a HbA1C of 7% to 8%, never lower,” he responded. “If a patient comes to me with a 7.9% A1C test result, I would say that’s fine. “When someone on drug treatment has a 6.5% A1C, I would stop one of the drugs. When you get into the lower range—that is, below 7% there’s an increased risk of causing hypoglycemia, which can be severe and life threatening. The only exception would be the person on diet alone where hypoglycemia is not a risk and where you would encourage the patient to continue their diet and exercise to maintain the level of 6.5%.”

Added September 22, 2012 : Soon after this post went up on our website, this review was published in the Cochrane Library. It did not find any significant reduction in either death from any cause or death from heart disease when intensive glycaemic control  was compared with conventional control.

Maryann Napoli, Center for Medical Consumers©

For more on this topic, read “Diabetes 2 drugs: risks without benefits”. and this “How risky is having diabetes 2?”.

Posted in Conflict of Interest, Diabetes 2, Diet & Exercise, Drugs, Heart, Type 2 Diabetes | Tagged: , , , , , , | 2 Comments »

How risky is diabetes 2?

Posted by medconsumers on March 28, 2011

There is, we are told, an “epidemic” of diabetes 2 in the U.S. Never mind that the definition of who has this condition was expanded in the 1990s, thus turning more than a million people into diabetics overnight. One of the worst things about diabetes 2 is its increased risk of potentially fatal heart problems. In time, however, research would show the drugs prescribed to cut the chance of this happening will themselves increase the risk of potentially fatal heart problems. Now a new study shows that people who receive a diabetes diagnosis after the age of 60 are not at same risk for heart problems as those diagnosed at younger ages.

Well, if you’re straining to find something positive in this bleak picture, as I am right now, this seems like something to cling to.

The new study, called the British Regional Heart Study, included only men—a problem right there for the other half of the population. The 4,045 men, age 60 to 79 years, were screened for diabetes 2 from 1978 to 1980 and asked to answer extensive questionnaires. The research team was led by Dr. S. Goya Wannamethee, University College, London, UK.

All were divided into four groups: Men who did not have diabetes or a heart attack; men with a prior heart attack but no diabetes; men with diabetes for more than 16 years and diagnosed before age 60 (early onset); and men with diabetes for at least 4 ½ years and diagnosed with diabetes after age 60 (late-onset).

Here’s what the British researchers found in the nine-year duration of their study: 9% of the men without diabetes or heart attack died from heart disease or suffered a major cardiovascular event (e.g., stroke, heart attack). Although a heightened chance of these “events” goes with a diabetes diagnosis at any age, the late-onset diabetics had a lower risk.

So how large is a man’s chance of suffering a cardiovascular complication of diabetes 2? The risk rises to 22% in the early-onset diabetes group and 16% in late-onset group. Put another way: 78%of the diabetics at either level of risk will not have a heart attack or premature death in the next nine years. The highest risk (26%) is for the men without diabetes who have suffered a heart attack. Are you ever old enough to stop thinking that diabetes will do you in prematurely? Yes, according to the editorial that accompanied this study. By the time a man hits age79, his risk of heart disease death is already high.

This is a small study that didn’t have enough participants to come to a firm conclusion—only 107 of the 4,045 men had early-onset diabetes. Still, the British researchers noted, earlier studies have also “suggested that the impact of diabetes on mortality decreases with increasing age at onset.”

In the editorial, Dr. Iskandar Idris, University of Sheffield, UK, cites a common, but evidence-free, treatment that is also based on the assumption that diabetes 2 confers the same level of heart disease risk to all. “Current cholesterol guidelines urge doctors to treat patients with diabetes to low LDL-cholesterol targets—less than 100 mg/dL—even though there is a lack for evidence to support this target.”

This study appeared in a recent issue of Archives of Internal Medicine as part of its ongoing “Less is More” series that illustrates “How Less Health Care Can Result in Better Health.”

More to think about

-In his book Overtreatment, H. Gilbert Welch, MD, describes how the definition of diabetes 2 changed since he was in medical school (1970s), “If you had a fasting blood sugar over 140, then you had diabetes. But in 1997 the Expert Committee on the Diagnosis and Classification of Diabetes Mellitus redefined the disorder. Now if you have a fasting blood sugar over 126, you have diabetes. So everyone who has a blood sugar between 126 and 140 used to be normal but now has diabetes. That little change turned over 1.6 million people into patients.”

-Nortin Hadler, MD, believes what is now called diabetes 2 is largely a construct invented by the pharmaceutical industry. Read this 2009 interview. He is the author of Worried Sick. A prescription for health in an overtreated America, which has a section on diabetes 2.

-See this 2009 study showing which oral diabetes 2 drugs are riskier than others. Only generic and drug class names are used throughout this medical journal article.

Maryann Napoli, Center for Medical Consumers

Posted in Chronic Conditions, Diabetes 2, Drugs, Heart, statins | Tagged: , , , , | 2 Comments »

Diabetes 2 drugs

Posted by medconsumers on March 22, 2010

Whenever I read that a common medical practice has just been proven to be either useless or outright dangerous, I always wonder how the prescribing physicians inform their patients. Do they call each one immediately? Or do they just wait until the patient comes in for a follow-up visit? I got to ponder these questions all over again recently when I read about two new studies that explored aggressive drug treatment of people with diabetes 2. Both studies took off from the fact that such people are at high risk for heart attack, stroke, and premature death. Both tested the common medical assumption that extreme reductions in heart-related risk factors—high blood pressure and high cholesterol—would result in equivalent reductions in heart attack, stroke, etc. Both studies showed that using drugs to make extreme reductions in blood pressure and cholesterol provided zero benefit to people with diabetes 2. And in the case of blood pressure reduction, the result was a higher incidence of serious harm.

Both studies were published recently in the online version of The New England Journal of Medicine (See Lipid-lowering study and the blood pressure lowering study.) In the one that looked at blood pressure reduction, all participants had diabetes 2, but only 34% also had heart disease. Half of the 4,733 study participants were randomly assigned to bring their systolic blood pressure to 120 mm Hg or below; and the rest aimed for 140 mm Hg or below. No new drugs were under review in this study. All the participants were taking the standard range of anti-hypertension drugs that have been in use for years. After nearly five years of follow-up, there was no difference between the two groups in the number of heart attacks, deaths, or strokes. The more intensive reduction in blood pressure, however, came with more serious adverse events (SAEs), including death and disability (3% vs. 1%). The greater proportion of SAEs in the aggressively treated group was attributed to the fact that they were taking one or two more anti-hypertension drugs than the other participants. Known risks of drug-induced extreme reductions in blood pressure include dangerously low blood pressure and heart rate.

The second study involved the extreme reduction of two fatty acids in the blood—triglycerides LDL cholesterol. It, too, found no benefit to such extreme measures, but at least this treatment did not kill more study participants than the less-aggressive reductions…at least in the 4 ½ years it lasted. In this study, half the participants took the cholesterol-lowering statin drug called simvastatin (brand name: Zocor) and the rest took a two-drug combination: simvastatin plus a fibrate drug (brand name: TriCor).

Both studies are part of a landmark study called the Accord, which explored three aggressive treatments for diabetes 2 and came up empty. Sponsored by the U.S. National Heart, Lung, and Blood Institute, Accord made headlines two years ago when the first of its studies had to be stopped ahead of schedule because there were more deaths among the participants given drugs to reduce their blood sugar (glucose) levels well below normal levels.

The same online issue of the New England Journal of Medicine featured two additional studies from The Navigator Study Group. Both used drug therapy to prevent people with impaired glucose tolerance from developing diabetes 2. Both overturned the medical wisdom that people with rapid increases in blood sugar following a meal were headed for heart disease. The 9,300 people in this study either had heart disease and impaired glucose tolerance or were at very high risk for heart disease. At five years, a drug (nateglinide, brand name: Starlix) that increases insulin secretion tested in this trial proved to be no better than a placebo in reducing the chance of developing diabetes 2 or heart problems. And lastly, the other trial from The Navigator Study Group tested the anti-hypertensive drug (valsartan, brand name: Diovan) in a similar group of patients and produced nearly similar disappointing results at five years. The Navigator Study Group is supported by Novartis Pharma, maker of both drugs in these two studies.

For more information

●This article was about drug therapy for extreme reductions in blood sugar levels. To learn more about drugs for less aggressive reductions, read “Diabetes drugs–risks without benefits.”

●If you want to know more about the three Accord studies, click here.

●The Accord results indicate that lowering systolic blood pressure below 135 does not benefit people with diabetes 2. Hypertension expert, Jim Wright, MD, found that studies have failed to prove that reducing blood pressure below 140/90 benefits anyone. See this 2009 interview with Dr. Wright: “No benefit to reducing blood pressure below 140/90.”

●Type 2 diabetes is largely due to lack of exercise and poor eating habits. The recommended exercise regimen need only be at least one half-hour of brisk walking five times a week. See “You can be fat and fit:” an interview with researcher Dr. Steve Blair. And to learn how to eat well and lower your risk of type 2 diabetes and other chronic conditions, read Michael Pollen’s new book entitled, Food Rules.

Maryann Napoli, Center for Medical Consumers(c)

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Posted in Children's Health, Drugs, hypertension, Men's Health, Women's Health | Tagged: , , , , , , | Leave a Comment »

Type 2 diabetes drugs: risks w/o benefit

Posted by medconsumers on December 14, 2009

Yet another study, this one conducted in the U.K, has shown that the oral drugs typically prescribed for people with type 2 diabetes are killing some of them; and many more have suffered heart attacks and congestive heart failure while on the drugs. Ironically, these are the very conditions that the drugs are intended to prevent. The British Medical Journal recently published findings from a 15-year database of more than 91,000 people with type 2 diabetes. The drugs they were taking—Avandia, Actos, Glucophage, and Amaryl—will be familiar to Americans. This is the eleventh published study to acknowledge the fact that oral hypoglycemic drugs are associated with an increased risk of serious harms. This one shows that some are riskier than others.

For those of you who are on one of these drugs, I provide access to the new study and leave it to your doctor to explain. I want to move on to the larger issue of why doctors continue to prescribe these dangerous drugs and how they got on the market in the first place. That last point is more easily addressed. Drugs most often receive FDA approval on the basis of what researchers call surrogate endpoints, for example, blood sugar levels are controlled, blood pressure or cholesterol is lowered, etc. The studies are usually too short in duration to prove what matters most to the people taking the drugs—i.e., they cut the chances of heart attack, stroke, etc.

I put the question of why doctors continue to prescribe these drugs in the face of so much proven danger to Nortin M. Hadler, MD, whom I consider the informed-skeptic-in-chief on this topic. Dr. Hadler is a professor of medicine and microbiology/immunology at the University of North Carolina, Chapel Hill. He is the author of two books, each with excellent sections devoted to type 2 diabetes (see below). Of course, the place to start questioning Dr. Hadler is the very definition of type 2 diabetes, which has been expanded over the years to include more and more people.

Dr. Hadler had a ready answer, “I don’t think America realizes how much input industry has on the medical organizations and their thought leaders who are involved in writing these definitions and treatment guidelines. Several of these entities are so heavily underwritten as to be almost wholly owned subsidiaries of the pharmaceutical industry. Professional meetings have much more the tone and the feel of the marketplace than they do of the academy. And all of this happened in the last 20 years.

“There are several pharmaceutical industry-supported medical groups that compete to establish standards of care for type 2 diabetes and related conditions. Some endocrinologists believe that type 2 diabetes, obesity, high blood pressure, and high cholesterol—all cluster together because they are parts of a single metabolic syndrome, which responds poorly to the treatment of its components. Others argue strenuously for the treatment of one or the other components [of metabolic syndrome]. Rather than choosing meaningful effectiveness as their battle cry, they are more interested in turf wars. The cardiologists are averse to this metabolic syndrome notion and want to pull out cholesterol and maybe hypertension as the most important risk factors to treat. The Endocrine Society and the American Diabetes Association finally got together and came out with their definition of type 2 diabetes and guidelines for lowering blood sugar.

“All of this is driven by the belief that if we normalize cholesterol or blood sugar we will improve longevity and decrease the incidence of blindness, kidney failure, stroke, heart attacks and leg ulcers. The thought leaders are so convinced of their belief that they focus on treating the blood sugar and to question whether they are treating the patient seems unnecessary. Their shortsighted efforts are rewarded with renown by the pharmaceutical industry. Almost all the thought leaders are heavily involved in drug trials where they are paid for studying the drugs. And almost all are vying for a place on the committees that set treatment guidelines.

“We now have three randomized controlled trials of oral hypoglycemic drugs in the treatment of type 2 diabetes and based on these three, we doctors cannot offer any meaningful assurance whatsoever that taking these drugs will decrease the likelihood of having a stroke, death before your time, amputation, renal failure, blindness. Anybody who tells you otherwise is exercising firm beliefs in the face of the evidence. They are wont to argue that oral hypoglycemics might have proven effective if we had done a bigger and/or longer trial. Such an argument is on the thinnest of ice. The available trials are impressive for their duration (measured in over a decade for two of the trials) and their size. Little of importance, if anything, has been missed.

“Maybe it’s time to address the other aspect of the metabolic syndrome that is too long and too often ignored. Most people who fall into the metabolic cluster are facing serious socioeconomic challenges in our society for which type 2 diabetes is one surrogate measure and for which pharmaceuticals are irrelevant.”

When I asked Dr. Hadler about metformin, the oldest and some doctors believe the safest diabetes 2 drug, he was unmoved by the British study that showed it to be effective at reducing the risk of heart attack, stroke, etc. “When you look carefully at that study, you will see the finding [of effectiveness] was not statistically significant [which means it could be due to chance].” As someone who has done an in-depth assessment of this landmark study, called the United Kingdom Prospective Diabetes Study, Dr. Hadler states, “…we doctors cannot offer any meaningful assurance whatsoever that taking these drugs will decrease the likelihood of having a stroke, death before your time, amputation, renal failure, blindness.”

Dr. Hadler is the author of The Last Well person. How to stay well despite the health-care system and Worried Sick. A prescription for health in an overtreated America, each has a strong section on type 2 diabetes. He appears frequently on National Public Radio.

For More Information:
Type 2 diabetes is largely due to lack of exercise and poor eating habits. See our 2008 interview with Dr. Steve Blair on the importance doing at least one-half hour of brisk walking five or more times a week. And to learn how to eat well and lower your risk of type 2 diabetes and other chronic conditions, read Michael Pollen’s new book entitled, “Food Rules.”

If you would like to know more about how the pharmaceutical industry brings the thought leaders around to its way of thinking, read Our Daily Meds by former New York Times business reporter Melody Petersen.

Maryann Napoli, Center for Medical Consumers(c)

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Posted in Chronic Conditions, Conflict of Interest, Drugs, Heart | Tagged: , , , , , , , , , , , , , | 2 Comments »